FLUMIST SPRAY

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

INFLUENZA VIRUS TYPE A (H1N1); INFLUENZA VIRUS TYPE A (H3N2); INFLUENZA VIRUS TYPE B

Disponible desde:

ASTRAZENECA CANADA INC

Código ATC:

J07BB03

Designación común internacional (DCI):

INFLUENZA, LIVE ATTENUATED

Dosis:

10000000FFU; 10000000FFU; 10000000FFU

formulario farmacéutico:

SPRAY

Composición:

INFLUENZA VIRUS TYPE A (H1N1) 10000000FFU; INFLUENZA VIRUS TYPE A (H3N2) 10000000FFU; INFLUENZA VIRUS TYPE B 10000000FFU

Vía de administración:

NASAL

Unidades en paquete:

5X0.2ML SPRAYER

tipo de receta:

Schedule D

Área terapéutica:

VACCINES

Resumen del producto:

Active ingredient group (AIG) number: 0352747002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2015-11-04

Ficha técnica

COPYRIGHT 2010, 2013, 2014 ASTRAZENECA CANADA INC.
_ _
Page 1 of 25
PRODUCT MONOGRAPH
FLUMIST
®
Influenza Vaccine (live, attenuated)
Intranasal spray
(ATC Code: J07BB03)
AstraZeneca Canada
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Manufactured by MedImmune, LLC
Submission Control Number: 173815
Date of Approval: 30 April 2014
FLUMIST
®
is a registered trademark of MedImmune licensed to AstraZeneca.
COPYRIGHT 2010, 2013, 2014 ASTRAZENECA CANADA INC.
_ _
Page 2 of 25
TABLE OF CONTENTS
PAGE
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.............................................................. 3
DESCRIPTION
..........................................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................... 3
CONTRAINDICATIONS..........................................................................................
3
WARNINGS AND PRECAUTIONS
........................................................................
4
ADVERSE REACTIONS
..........................................................................................
5
DRUG INTERACTIONS
........................................................................................
10
DOSAGE AND ADMINISTRATION
....................................................................
10
OVERDOSAGE
.......................................................................................................
12
ACTION AND CLINICAL
PHARMACOLOGY................................................... 12
STORAGE AND STABILITY
................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 13
PART II: SCIENTIFIC INFORMATION
....................................